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Clinical Trials/NCT01776931
NCT01776931
Completed
Not Applicable

Determination of Lysine Requirements in Healthy Pregnant Women Using the Indicator Amino Acid Oxidation Technique

University of British Columbia1 site in 1 country20 target enrollmentJanuary 2012
ConditionsPregnancy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy
Sponsor
University of British Columbia
Enrollment
20
Locations
1
Primary Endpoint
13 carbon dioxide production
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

Amino acids are building blocks of protein in our body. It is important that pregnant women eat adequate amount of protein/amino acids to ensure healthy growth and development of the fetus.Lysine is an amino acid that is present in high amounts only in animal foods (meat) and not much in plant foods such as wheat. Currently , it is not known how much lysine is needed to eat during pregnancy.

Current Dietary Reference Intake recommendations for amino acid requirements are based on non-pregnant adults, and minimally based on pregnancy-specific data.To the investigators knowledge, there is no scientific information regarding the amount of lysine needed at different stages of pregnancy.

The investigators hypothesize that current recommendations for lysine intake in pregnant women are underestimated. The investigators also hypothesize that the lysine requirements will be greater during the later stages of pregnancy, compared to early stages.

The purpose of this study is to determine lysine requirements in healthy pregnant women 19-40y,(1st and 3rd trimester) using a modern, safe and quick technique called the indicator amino acid oxidation technique and to compare lysine requirements during early (15-18 weeks last menstrual period) late (33-36 weeks last menstrual period) stages of pregnancy.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
June 2014
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rajavel Elango, PhD

Principle Investigator

University of British Columbia

Eligibility Criteria

Inclusion Criteria

  • Singleton pregnancy
  • Maternal age 19-40y
  • Early stage of pregnancy(15-18 weeks) and late stage of pregnancy(33-36 weeks)
  • In good health (free of chronic/acute illness, full range of physical mobility)
  • Healthy pre-pregnancy body mass index

Exclusion Criteria

  • Subjects outside the age range of 19-40y
  • Women pregnant with more than one child
  • Body mass Index less than 18.5kg/m2 or greater than 25 kg/m2
  • less than 18 months between current pregnancy and last pregnancy
  • History of spontaneous abortion,pre-term birth, preeclampsia/eclampsia, gestational diabetes, pregnancy-related anemia, pregnancy related jaundice
  • Existing metabolic disease
  • Substance dependance (i.e. alcohol, cigarette, illicit drugs)
  • Allergic to eggs and egg protein
  • Severe nausea and vomiting during pregnancy

Outcomes

Primary Outcomes

13 carbon dioxide production

Time Frame: 8 hours (1 study day)

Urine and breath samples will be collected during the study to measure the rate of oxidation of tracer in expired breath and flux by enrichment in urine.

Study Sites (1)

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